Ancillary Study Guidelines: Overview

The Ancillary Studies Subcommittee (ASSC) of the Steering Committee will evaluate protocols that enhance the ability of Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) consortium to:

Document the efficacy and complications of bariatric surgery in the adolescent surgical patient and its role in the overall management of obesity prior to and through the emerging years of adulthood

Address other important clinical, epidemiologic and basic science questions related to teenage obesity and surgical intervention

Definition of studies ancillary to Teen-LABS

Ancillary studies propose questions and test hypotheses that are relevant to the goals and purposes of Teen-LABS but are not addressed by the Teen-LABS-funded core or other substudy protocols. An ancillary study, by definition, derives its financial support from sources other than the funds awarded by NIDDK for support of the Teen-LABS consortium. While ancillary studies will generally utilize information about or specimens obtained from patients already enrolled in the Teen-LABS core database, they may involve additional study sites, investigators, specimen and data collection, procedures, patients or other treatments. By contrast, substudies are projects conducted by Teen-LABS investigators at participating Teen-LABS sites with costs that are covered by the funds allocated to Teen-LABS.

The Teen-LABS consortium will collect a large and uniquely well-characterized sample of obese adolescents and will follow them before, during and after bariatric surgery. To make the best possible use of this extraordinary resource, members of the Teen-LABS Consortium encourage other investigators to develop ancillary studies in conjunction with other investigators within and outside of Teen-LABS. Each ancillary study must include at least one Teen-LABS coinvestigator.

The ASSC will conduct a review of all proposed ancillary studies and must approve all ancillary studies recommended for its consideration to ensure that they do not impose an unacceptable burden on Teen-LABS staff or participating patients or conflict with the aims of Teen-LABS. Data collection for funded ancillary studies may not proceed without the approval of the ASSC.